With the DEA’s historic approval of the trial, this means medical marijuana grown by the government at the University of Mississippi will soon be on its way to 76 combat veterans who are set to smoke the cannabis to determine its potential to help soothe the stress of readjusting to civilian life.
According to its sponsor, the California-based non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the long-awaited study marks the first time, “a clinical trial intended to develop smoked botanical marijuana into a legal prescription drug has received full approval from U.S. regulatory agencies, including the DEA and the Food and Drug Administration (FDA).”
Funded by a $2.156 million grant from the Colorado Department of Public Health and the Environment awarded earlier this week, the research will involve veterans in both Maryland and Arizona. For Dr. Sue Sisley — who will treat half of the subjects in Phoenix, Arizona — the DEA approval marks an exceptional victory based in tenacity. Sisley co-authored the only FDA-approved randomized controlled human clinical trial to test the effects of cannabis as a treatment for PTSD back in 2010. After a series of setbacks, the study was approved by the Department of Health and Human Services (HHS) in 2014 only to face another issue: the government said it did not have enough marijuana to supply. Now the National Institute on Drug Abuse (NIDA) — which remains the only legal way of obtaining marijuana for research purposes — says it has grown enough marijuana to offer four potencies with varying rations of tetrahydrocannabinol (THC) and cannabidiol (CBD) for the trial.
“Excellent news: The DEA has finally issued my Schedule I license to conduct the PTSD/cannabis clinical trial in Phoenix, Arizona,” Sisley said through an email to supporters. “We hope to be fully underway by late May, screening and enrolling Arizona military veterans at our Scottsdale Research Institute SRI laboratory located in north Phoenix. Thank you to all the military veterans who stood by us. [This was] a great lesson in tenacity. Never give up.”
The study’s two sites, one in Arizona and one at Johns Hopkins University in Baltimore, Maryland, will be overseen by Dr. Marcel Bonn-Miller of the University of Pennsylvania’s Perelman School of Medicine. The study will also involve contributions from the University of Colorado School of Medicine and the University of Colorado, Boulder.
“We are thrilled to see this study overcome the hurdles of approval so we can begin gathering the data,” Amy Emerson, the executive director and director of clinical research for the MAPS Public Benefit Corporation said through a release. “This study is a critical step in moving our botanical drug development program forward at the federal level to gather information on the dosing, risks, and benefits of smoked marijuana for PTSD symptoms.”
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